BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 10275872 · Received July 15, 2020

    Report

    Report Number
    2648988-2019-00105
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    November 5, 2019
    Report Date
    November 6, 2019
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THE DEVICE WAS NOT RETURNED FOR EVALUATION. A FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE DUE TO PRODUCT WAS NOT RECEIVED TO PERFORM A COMPLETE INVESTIGATION. THE REPORTED COMPLAINT IS UNCONFIRMED. NO LOT NUMBER WAS IDENTIFIED, THEREFORE THE DHR REVIEW COULD NOT PERFORMED. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(6) , DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6) , ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER REPORTED THAT THE INS5010 HERMETIC LUMBAR CATHETER, CLOSED TIP WAS CRACKED ON (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED ON 15NOV2019 STATING THAT DEVICE WAS USED IN A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE. THE DEVICE WAS IN CONTACT WITH PATIENT; THERE WAS NO INJURY REPORTED. THE INCIDENT WAS FOUND AFTER THE PROCEDURE; DURING PATIENT ASSESSMENT IN THE INTENSIVE CARE UNIT (ICU). THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741220 HERMETIC LUMBAR CATHETER, CLOSED TIP N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1